Status:
COMPLETED
Non-inferiority of Short-term Catheterization Following Fistula Repair Surgery
Lead Sponsor:
EngenderHealth
Collaborating Sponsors:
World Health Organization
United States Agency for International Development (USAID)
Conditions:
Vaginal Fistula
Eligibility:
FEMALE
Phase:
NA
Brief Summary
This facility-based, multi-center randomized controlled trial (RCT) will test the non-inferiority of short-term (7 day) urethral catheterization compared to longer-term (14 day) urethral catheterizati...
Detailed Description
A vaginal fistula is a devastating condition, affecting an estimated 2 million girls and women across Africa and Asia. Finding ways of providing services in a more efficient and cost-effective manner,...
Eligibility Criteria
Inclusion
- Have a "simple" fistula, as determined at the end of fistula repair surgery (irrespective of the number of prior repair attempts and the cause of the fistula, with the exceptions noted under the exclusion criteria below)
- Have a closed fistula at completion of surgery
- Have a closed fistula 7 days after surgery (i.e. at the time of randomization)
- Understand study procedures and requirements
- Agree to return to the facility for one follow-up visit three month after the date of surgery
- Provide informed consent to participate in the study or in the case of non-emancipated minors, both consent to the study and receive proxy consent to participate in the study
- Have no contraindications precluding their participation.
Exclusion
- Have a fistula that is determined to be "not simple" (i.e. intermediate or complex)
- Have a fistula that is radiation-induced, associated with cancer or due to lymphogranuloma venereum (These cases will be excluded because the healing process is very different from fistula resulting from other causes. We expect there to be few cases of these fistulas at the study sites)
- Have a fistula that is not closed immediately after surgery or 7 days after surgery (i.e. at the time of randomization)
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
524 Patients enrolled
Trial Details
Trial ID
NCT01428830
Start Date
January 1 2012
End Date
August 1 2013
Last Update
January 19 2015
Active Locations (8)
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1
Hôpital Saint Joseph
Kinshasa, Democratic Republic of the Congo
2
Gondar University Hospital
Gonder, Ethiopia
3
L'Hôpital Préfectoral de Kissidougou
Kissidougou, Guinea
4
Kenyatta National Hospital
Nairobi, Kenya